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DESCRIPTIONAn integrated system providing magnetic resonance imaging (MRI)-guided focused ultrasound (MRgFUS) treatment is proposed as a noninvasive therapy for uterine fibroids and for pain palliation of bone metastases. MRgFUS is also being investigated for the treatment of other benign and malignant tumors.
Magnetic resonance-guided focused ultrasound (MRgFUS) is a non-invasive treatment that combines 2 technologies, focused ultrasound and magnetic resonance imaging (MRI). The ultrasound beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. The ultrasound waves from each sonication are focused at a focal point which has a maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid rise in temperature (i.e., to approximately 65°C to 85°C), which is sufficient to achieve tissue ablation at the focal point. In addition to providing guidance, the associated MRI can provide on-line thermometric imaging that provides a temperature “map” that can further confirm the therapeutic effect of the ablation treatment and allow for real-time adjustment of the treatment parameters.
The U.S. Food and Drug Administration (FDA) has approved the ExAblate® MRgFUS system (InSightec, Inc., Haifa, Israel) for 2 indications; treatment of uterine fibroids (leiomyomata) and palliation of pain associated with tumors metastatic to bone. The ultrasound equipment is specially designed to be compatible with MR magnets and is integrated into standard clinical MRI units. It includes a patient table, which includes a cradle housing the focused ultrasound transducer in a water or light oil bath. Some models of the device have a detachable cradle; only certain cradle types can be used for palliation of pain associated with metastatic bone cancer.
As noted, FDA has approved an MRgFUS for treatment of uterine fibroids, which is one of the most common conditions affecting women in the reproductive years. Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain. There are several approaches that are currently available to treat symptomatic uterine fibroids: hysterectomy; abdominal myomectomy; laparoscopic and hysteroscopic myomectomy; hormone therapy; uterine artery embolization; and watchful waiting. Hysterectomy and various myomectomy procedures are considered the criterion standard treatment.
For treating pain associated with bone metastases, the other FDA approved indication, the aim of MRgFUS treatment is to destroy nerves in the bone surface surrounding the tumor. Metastatic bone disease is one of the most common causes of cancer pain. Existing treatments include conservative measures (e.g., massage, exercise), pharmacologic agents (e.g., analgesics, bisphosphonates, corticosteroids). For patients who fail the above treatments, standard care is use of external beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy, and there is a need for alternative treatments for these patients. (One option, radiofrequency ablation, is addressed in related medical policy Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors).
MRgFUS is also being investigated for treatment of other tumors, including breast, prostate, and brain tumors.
In October 2004, the U.S. Food and Drug Administration (FDA) approved via the premarket application (PMA) process, the ExAblate® 2000 System (Insightec, Inc., Haifa, Israel) for “ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.” Treatment is indicated for women with a uterine gestational size of less than 24 weeks who have completed childbearing.
In October 2012, the FDA approved the ExAblate® System, Model 2000/2100/2100 VI via the PMA process. The intended use of the device is for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy. The device was evaluated through an expedited review process. The FDA required a post-approval study with 70 patients to evaluate the effectiveness of the system under actual clinical conditions.
Magnetic resonance imaging (MRI)‒guided high-intensity ultrasound ablation may be considered medically necessary for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy.
Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation is considered investigational in all other situations. This includes, but is not limited to, its use in the following situations:
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/31/2005: Approved by Medical Policy Advisory Committee (MPAC)
6/6/2005: Code Reference section completed
12/13/2006: Policy reviewed, ablation of tumors other than uterine fibroids as investigational added
1/8/2009: Policy reviewed, no changes
4/27/2010: Policy Title changed - "High-Intensity" and "Ablation of" were removed and "Focused (MRgFUS) for the Treatment" was added. Policy Description section was revised to add information about the ExAblate® 2000 system. Policy statement revise to add "palliative treatment of bone metastases" is considered investigational for treatment other than uterine fibroids.
04/20/2011: Policy description updated; policy statement unchanged. Added FEP verbiage to the Policy Exceptions section.
03/27/2012: Policy reviewed; no changes.
07/16/2013: Deleted "for the Treatment of Uterine Fibroids and Other Tumors" from the policy title. Policy description updated to reflect the scope of the policy. Policy statement re-written into one investigational statement; intent unchanged. Deleted outdated references from the Sources section.
03/17/2014: Policy reviewed; no changes.
03/17/2015: Policy title changed from "MRI-Guided High Focused Ultrasound (MRgFUS)" to "MRI-Guided Focused Ultrasound." Policy description updated to add information regarding treating pain associated with bone metastases. Added the following policy statement: Magnetic resonance imaging (MRI)‒guided high-intensity ultrasound ablation may be considered medically necessary for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy. Revised investigational statement to state that MRI-guided high-intensity ultrasound ablation is considered investigational in all other situations. Removed "Pain palliation for patients with metastatic bone cancer;" from investigational criteria. Policy guidelines updated to add medically necessary and investigational definitions. Code Reference section updated to change "Investigational Codes" to "Covered Codes" and add ICD-9 diagnosis codes 170.0-170.8, and 198.5.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.109
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.